Lee Spach, Director, Global Product & Supply Chain Security, Biogen, says there are about 35,000 online pharmacies in the world. Ninety-eight percent are fake. They transact billions of dollars annually and seriously endanger patients. The criminals can expect a large return on their investment, with relatively little risk. Spach and Biogen are trying to change that. You can help.
Managing clinical supplies is hard. Not hard like string theory — more like organizing a family vacation with your adult siblings and all their children. Clinical supplies management sits at the intersection of multiple disciplines, each with its unique perspectives and priorities. Their collective attention may be difficult to hold for something as seemingly trivial as packaging. However, clinical packaging is critical to the success of a program and a company, and an effective request for proposal (RFP) will guide you to the right packaging partner for your journey to product approval.
Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.
Gone are the days when we could count the number of immunology drugs on the market with our two hands. Today, the market is crowded with not only an abundance of originator biologics, but also an increasing supply of biosimilar products
The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.
Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets
The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.
Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex.
Clinical development is the most costly aspect of getting drug, medical device or diagnostic to market. Previously priced at $1.3 billion, getting a product approved is now estimated to cost more than $5 billion, according to a recent analysis by Forbes. If you decide to entrust management of your clinical trial to a contract research organization (CRO), what criteria should you look for in a partner to ensure the most reliable results with the greatest efficiencies at the most affordable price?
This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes. For creation of high-density cell banks, Chinese hamster ovary (CHO) cells were expanded using a bioreactor system operated in perfusion mode.
How much does quality cost? Most companies would be hard-pressed to translate “quality” into dollars and cents. What they realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
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Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
When selecting a bioreactor, It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.
The ADC field is in a transitional period. Older approaches to conjugate composition and dosing regimens still dominate the ADC clinical pipeline, but preclinical work is driving a rapid evolution in how we strategize to improve efficacy and reduce toxicity towards better therapeutic outcomes. In an indication of future directions for the field, antibody conjugates bearing non-cytotoxic small molecule payloads are being developed to reduce side effects associated with treatment of chronic diseases.
A larger-scale adoption of single-use technology may continue to be delayed as biopharma manufacturers must have access to a reliable supply chain that successfully delivers product to customers.
Even with forecasting and building out a sizeable buffer inventory, clinical sites may still not always have the appropriate kits on hand to dispense to patients. Why?
Through proper planning of your automation integration, you can eliminate costly errors and missteps and focus on developing efficient, future-proof automation strategies.
